Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Electrosurgical Clip Cutting System. Final order.

The Food and Drug Administration (FDA or we) is classifying the endoscopic electrosurgical clip cutting system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the endoscopic electrosurgical clip cutting system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Proposed standards for reporting outcomes of treating biliary injuries.

BACKGROUND: There is no standard nor widely accepted way of reporting outcomes of treatment of biliary injuries. This hinders comparison of results among approaches and among centers. This paper presents a proposal to standardize terminology and reporting of results of treating biliary injuries. METHODS: The proposal was developed by an international group of surgeons, biliary endoscopists and interventional radiologists. The method is based on the concept of "patency" and is similar to the approach used to create reporting standards for arteriovenous hemodialysis access. RESULTS: The group considered definitions and gradings under the following headings: Definition of Patency, Definition of Index Treatment Periods, Grading of Severity of Biliary Injury, Grading of Patency, Metrics, Comparison of Surgical to Non Surgical Treatments and Presentation of Case Series. CONCLUSIONS: A standard procedure for reporting outcomes of treating biliary injuries has been produced. It is applicable to presenting results of treatment by surgery, endoscopy, and interventional radiology.

Analgesia y sedación para endoscopia digestiva superior diagnóstica e intervencionista en pediatría / Analgesia and sedation for diagnostic and interventional upper gastrointestinal endoscopy in pediatrics

La endoscopia digestiva superior es parte integrante fundamental de la práctica de la gastroenterologíapediátrica. Debe ser realizada por personas con experiencia en este tipo de procedimiento. La posibilidad de brindar una adecuada sedación y analgesia de forma segura y efectiva garantiza la estabilidad y comodidad del paciente por lo que se considera como un componente importante del procedimiento. En los últimos años hay un mayor uso de la sedación para este tipo de procederes. En Cuba, se realizan a diario más de mil endoscopías semanales, alrededor del 19% corresponde a pacientes pediátricos. Llevarlos a cabo con éxito, no es solo obtener resultados valiosos para el diagnóstico y la investigación; sino también, es tener al paciente sedado, sin dolor, dispuesto a incorporarse con rapidez a su tarea de jugar y estudiar.

Digestive endoscopy is an important tool in the practice of pediatric gastroenterology. It should be realized by experienced endoscopist. The possibility of a proper sedation and analgesia in a safe and effective waygarantees the stability and and comfort of the patient. It is considered an important component of the procedure. In the recent past years there is an increase in the sedation for endoscopy. In Cuba, more than athousand endoscopies are done dayli. 19% of them are done in pediatric patients. To do the procedure successfully is not only to have a proper diagnosis; it is also to have the patient properly sedated, without pain and ready to play and to go back to school.

Proceedings of a preliminary workshop at Gastro 2009--narrow banding imaging in digestive endoscopy: clinical outcome of classification (Omed-Jges Educational Meeting held on 22 November, 2009).

This publication reports the proceedings of the preliminary meeting of the working party that met at Gastro 2009 during the World Congress in London. The purpose of the preliminary meeting was to consider the areas that require attention, to discuss some of the findings that have already been published and to agree on the way forward. Our reason for publishing these proceedings is to stimulate interest in this venture and to provide the opportunity for input from the endoscopy community worldwide. The next meeting of the working party will be at the JGES Society meeting in Aomori in April 2011 when we hope to prepare a preliminary classification. This will be presented for general discussion and debate at the International Congress of Endoscopy (ICE) in Los Angeles in September 2011.

Ingestión de sustancias Cáusticas: reporte de un caso y revisión de la literatura / Ingestion of caustic substances: a case report and literature review

Introducción: La ingestión de sustancias cáusticas (IC) en niños, continúa siendo un campo difícil, debido a la poca clara relación entre los signos y síntomas y la extensión del daño del esófago.Objetivo: Describir el caso de un niño con IC y revisar la literatura del tema. Reporte del caso: Se trata de un masculino de 1 año 8 meses de edad, sin antecedentes de importancia, quien luego de ingesta accidental de líquido de radiador contenido en un frasco de yogurt, presenta vómito en 15 oportunidades. En Centro de Salud luego de la colocación de sonda nasogástrica para lavado gástrico es remitido a un Tercer Nivel de Atención, donde se le realiza una endoscopia digestiva alta (EVDA) luego de 28 horas de la IC. El reporte de la EVDA, indicó esofagitis caústica grado IIc, gastropatía severa, y píloro no franqueable con lesiones concéntricas. El manejo incluyó ayuno, líquidos endovenosos, corticoides, penicilina, y ranitidina Discusión: La EVDA, es el método más eficiente para evaluar la mucosa del tubo digestivo superior luego de la IC, que puede tener efectos catastróficos o puede resultar inofensiva. Se ha intentado correlacionar los signos y síntomas iniciales con la gravedad de las lesiones para evitar la realización de una EVDA innecesaria, sin embargo, sigue siendo controversial este tema. El manejo médico de la IC incluye antibióticos, esteroides y bloqueadores H2. Entre las complicaciones de la IC se encuentran la perforación, la mediastinitis, las fístulas a grandes vasos, la penetración al estómago y las estenosis.

Introduction: The ingestion of caustic substances (CI) in children, remains a difficult, due to lack clear relationship between the signs and symptoms and the extent of damage of the esophagusObjective: To describe the case of a child with CI and review the literature on the subject. Case report: This is a male 1 year 8 months old, with no previous medical history, who after accidental ingestion of radiator fluid contained in a jar of yogurt, vomiting occurs in 15 opportunities. Health Center after placement of a nasogastric tube for gastric lavage is referred to a tertiary care, where she underwent an upper endoscopy (UE) after 28 hours of the CI. The report of the UE, said caustic esophagitis grade IIc, severe gastropathy, and pylorus not passable with concentric lesions. The managemen included fasting, intravenous fluids, steroids, penicillin, and ranitidine Discussion: . The UE, is the most efficient method to evaluate the upper gastrointestinal mucosa after the IC, which can have catastrophic effects and can be harmless. It has tried to correlate the signs and symptoms with the severity of injuries to avoid making an unnecessary UE, however, this issue remains controversial. The medical management of IC including antibiotics, steroids and H2 blockers. Complications of the IC are perforation, mediastinitis, fistulas to large vessels, penetrationto the stomach and stenosis.

Caustic ingestion in adults: the role of endoscopic classification in predicting outcome.

BACKGROUND: The ingestion of caustic substances induces an extensive spectrum of injuries to the aerodigestive tract which include extensive necrosis and perforation of the esophagus and stomach. The gold standard of safely assessing depth, extent of injury, and appropriate therapeutic regimen is esophagogastroduodenoscopy (EGD). The objective of this study was to report our clinical experience and to evaluate the role of a 6-point EGD classification system of injury in predicting outcomes in adult patients diagnosed with caustic agent ingestion. METHODS: The study was a retrospective medical chart review from 273 patients admitted to the Chang Gung Memorial Hospital in Tao-Yuan, Taiwan between June 1999 and July 2006 for treatment of caustic ingestion. The patients underwent EGD within 24 hours of admission and mucosal damage was graded using Zagar's modified endoscopic classification scheme. After treatment, patients were followed in the outpatient clinic for a minimum of 6 months. RESULTS: A total of 273 patients were included for analysis. Grade 3b injury was the most common caustic injury (n = 82, 30.03%), followed by grade 2b injuries (n = 62, 22.71%). Stricture was the most common complication (n = 66, 24.18%), followed by aspiration pneumonia (n = 31, 11.36%), and respiratory failure (n = 21, 7.69%). Compared to grade 3a mucosal injury, grade 3b mucosal injuries were at greater risk of prolonged hospital stay (odds ratio [OR]: 2.44; 95% confidence interval [CI]: 1.25-4.80), ICU admission (OR: 10.82; 95% CI: 2.05-200.39), and gastrointestinal (OR: 4.15; 95% CI: 1.55-13.29) and systemic complications (OR: 4.07; 95% CI: 1.81-14.07). CONCLUSION: In patients with caustic ingestion, EGD should be performed within 12 to 24 hours and categorized according to a 6-point scale. Patients with grade 3b burns identified on endoscopy have high rates of morbidity. The 6-point scale is useful for predicting immediate and long-term complications, and guiding appropriate therapy.

Avaliação endoscópica das valvuloplastias anti-refluxo: uma proposta de classificação / Antireflux surgery: a proposed classification

A grande difusão da cirurgia por videolaposcopia no tratamento da doença do refluxo gastroesofágico trouxe consigo a necessidade de avaliar seus resultados. Uma das maneiras de fazê-lo é através da endoscopia, analisando morfologicamente as fundoplicaturas. No presente estudo, avalia-se o aspecto endoscópico de 169 válvulas, em diferentes períodos pós-operatórios, para propor uma classificação. Os autores dividem, morfologicamente, as fundoplicaturas em cinco grupos: válvula tipo I, com uma ou duas pregas gástricas envolvendo o endoscópio; tipo II, com três ou quatro pregas envolvendo o endoscópio; tipo III, com cinco ou mais pregas envolvendo o endoscópio; tipo IV, número qualquer de pregas, porém com abertura do anel hiatal; e tipo V, sendo a válvula desfeita, compregas irregulares, e com recidiva de esofagite. No estudo, foram encontradas cinco fundoplicaturas do tipo 1,81 do tipo II, 60 do tipo III, 16 do tipo IV e 7 do tipo V

[Complexity index and analysis of digestive endoscopies at a university hospital]. / Indice de complejidad y análisis de los costes de las endoscopias digestivas en un hospital universitario.

BACKGROUND: In Spain neither the cost of digestive endoscopies nor the complexity index (CI) have been objectively estimated. Consequently, the profitability of an endoscopy unit cannot be evaluated. OBJECTIVES: 1: To classify endoscopies according to the time taken to accomplish them in order to estimate the CI and determine the relative value unit (RVU). 2: To evaluate the cost of each examination in order to determine the profitability of endoscopy as a diagnostic and therapeutic tool. 3: To measure unnecessary delays in examinations and to determine whether there are differences in the time an examination takes according to the endoscopist's experience and the patient's age or sex. MATERIAL AND METHODS: The cost per hour of an endoscopy room was estimated by dividing the cost per year of employees, equipment, maintenance and the hospital's general costs between the hours of work per year of the endoscopy team. The time taken to perform endoscopies was estimated and the result was used to calculate the RVI, the CI and the cost of 500 consecutive endoscopies. RESULTS: The annual cost amounted to 349,617.69 E. Staffing costs represented 65.5%, of which 56.3% were direct costs. Gastroscopy was taken as the RVU (cost = 27.52 E). Anoscopy was the simplest procedure (RVU = 0.61, cost = 15.08 E) and colonoscopy plus polypectomy was the most complex procedure (RVU = 4.41, cost = 74.28 E). The greater the experience of the member of staff performing the procedure, the less time it took (p < 0.01). CONCLUSION: CI was lowest for anoscopy (URV = 0.61) and highest for total colonoscopy plus polypectomy (URV = 4.41). Cost and exploration time depended on the endoscopist's experience. Staff represented the highest percentage of cost.

The use of a standardized terminology for comparison of free text and structured data entry.

The Minimal Standard Terminology (MST) for gastrointestinal endoscopy, the product of an international effort, is to be been used in a study comparing free text to structured reports of esophagogastroduodenoscopies (EGDs). This requires some assumptions and adaptations in order to map to the MST in a uniform and quantifiable manner. Initial mapping has suggested a number of problem areas which require further investigation.

The accuracy of diagnosis and procedural codes for patients with upper GI hemorrhage.

BACKGROUND: Little is known about the accuracy of diagnostic and procedural codes for common gastrointestinal (GI) conditions and endoscopic procedures. METHODS: Eight hundred eighty-two patients with upper GI hemorrhage admitted in 1994 to 1 of 13 regional hospitals were studied. Based on endoscopy reports, the source of hemorrhage, performance of upper endoscopy and use of endoscopic therapy were determined, and we assessed the sensitivity and positive predictive value of discharge codes for measuring the source of hemorrhage and use of upper endoscopy. RESULTS: The sensitivity and positive predictive value of principal diagnosis coding for source of hemorrhage were typically 85% to 95%. The sensitivity and predictive value of coding for upper endoscopy were 97.7% and 99.9%, respectively, and were 72.3% and 99.4%, respectively, for endoscopic therapy. Accuracy did not differ between the 4 major teaching and 9 other hospitals. CONCLUSIONS: Hospital-based diagnostic and procedural codes are a reasonably accurate source of data for clinical and outcomes analyses of upper GI hemorrhage. In particular, it is possible to discern from these data the source of hemorrhage and the overall use of upper endoscopy.

Hernia diafragmatica iatrogenica apos a realizacao de esofagogastrofundoplicatura por via abdominal: relato de um caso / Iatrogenic diaphragmatic hernia following abdominal esophagogastrofundoplication: a case report

Os autores descrevem o diagnostico e o tratamento cirurgico de um paciente portador de hernia diafragmatica iatrogenica produzida apos a realizacao de esofagogastrofundoplicatura pela tecnica de Nissen. O paciente era portador de hernia de hiato com esofagite de refluxo cronica foi submetido a esofagogastrofundoplicatura. No terceiro dia de pos-operatorio o paciente apresentou disfagia e dispneias instensas que ao estudo radiologico e tomografico computadorizado, demonstrou a presenca do fundo e corpo gastricos dentro da cavidade pleural esquerda com colapso parcial do pulmao esquerdo...